An interesting and useful way of providing cancer patients access to new drugs is to open clinical trials in expanded access programs, which are often smaller or stripped down versions of existing trials with less onerous monitoring compared to registration trials.

The advantage of this type of program is that patients continue to gain access to treatments, oncologists gain experience in using the new therapies and there is the possibility to improve patient outcomes compared to standard of care or best supportive care if there are no other options available.

In the US, expanded access trials typically run until a drug is made commercially available, thereupon patients are transferred to the marketed drug via Government or insurance payer schemes.  However, it has been suggested that in some countries, patients continue in the expanded access program until progression, even after the drug concerned has been approved.

We are currently researching the topic of expanded access clinical trials, so if anyone has any experience as a physician or patient, or wishes to add any commentary, we would welcome any comments either here on the blog or via email.

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